Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors
Trial Parameters
Brief Summary
This is a Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the variables of ML NK cell source. ML NK cells from an autologous source will be used for Arm 1, and ML NK cells from an allogeneic source will be used for Arm 2. The investigators hypothesize that ML NK cells from either an autologous source or allogeneic source are safe and tolerable in subjects with advanced and/or metastatic melanoma.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of histologically confirmed advanced or metastatic melanoma that has progressed after at least 12 weeks or a minimum of 2 doses of treatment with a standard of care PD1/PDL1 containing therapy (nivolumab, pembrolizumab, atezolizumab, or durvalumab). * Age: ≥18 years of age * Have an Eastern Cooperative Oncology Group Performance Status (ECOG) ≤ 2 at screening Form Arm 1 only: Patients must meet the eligibility criteria to undergo apheresis to obtain autlogous NK cells. * For Arm 2 only: Patient must have an available allogeneic NK cell donor who meets the eligibility criteria. * Adequate organ function as defined below: * Total bilirubin \< 2 mg/dL * AST(SGOT)/ALT(SGPT) \< 3.0 x ULN * Creatinine within normal institutional limits OR creatinine clearance \> 40 mL/min/1.73 m\^2 by Cockcroft-Gault Formula * Oxygen saturation ≥ 90% on room air * Ejection fraction ≥ 45% * Patients with a prior history of symptomatic CNS metastases must have received treatment